Vario-Cup System— 510(k) K221794

Substantially Equivalent

Waldemar Link GmbH & Co. KG

FDA 510(k) clearance K221794 for Vario-Cup System, Substantially Equivalent on 2022-07-20. Applicant: Waldemar Link GmbH & Co. KG.

Clearance details

Applicant: Waldemar Link GmbH & Co. KG
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 2022-06-21
Decision date: 2022-07-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Norderstedt, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.